Paracentesis

Abstract: Spontaneous bacterial peritonitis (SBP) is considered a bacterial infection of ascitic fluid without any intraabdominal, surgically treatable source of infection. Multiple variants of this infection with a different clinical setting and outcome have been described during the past decade. Bacterial translocation from the gut to mesenteric lymph nodes, depressed activity of the reticuloendothelial phagocytic system and decreased antimicrobial capacity of ascitic fluid seem to be the main steps in the pathogenesis of ascitic fluid infection. Diagnosis of ascitic fluid infection is based on clinical suspicion and analysis of ascitic fluid, especially white cell count and culture in blood culture bottles. A low threshold for performing an abdominal paracentesis is the key for an early diagnosis and treatment. A third-generation cephalosporin is the treatment of choice, achieving a cure rate higher than 80%. Nonazotemic patients with nonadvanced, uncomplicated SBP may be treated with oral ofloxacin. Prophylactic selective intestinal decontamination with oral norfloxacin is extremely useful in preventing SBP in patients that are at high risk for developing SBP, such as hospitalized cirrhotic patients with gastrointestinal hemorrhage or low ascitic fluid total protein. Primary or secondary long-term prophylaxis of SBP also decreases the incidence of SBP, but these patients should be carefully observed for detecting possible infections caused by quinolone-resistant organisms. Since long-term prognosis of SBP patients is poor, survivors should be considered for liver transplantation.

Abstract: Malignant ascites is a common manifestation of advanced cancers, and treatment options are limited. The trifunctional antibody catumaxomab (anti-epithelial cell-adhesion molecule x anti-CD3) represents a targeted immunotherapy for the intraperitoneal (i.p.) treatment of malignant ascites secondary to epithelial cancers. In this phase II/III trial (EudraCT 2004-000723-15; NCT00836654), cancer patients (n = 258) with recurrent symptomatic malignant ascites resistant to conventional chemotherapy were randomized to paracentesis plus catumaxomab (catumaxomab) or paracentesis alone (control) and stratified by cancer type (129 ovarian and 129 nonovarian). Catumaxomab was administered as an i.p. infusion on Days 0, 3, 7 and 10 at doses of 10, 20, 50 and 150 μg, respectively. The primary efficacy endpoint was puncture-free survival. Secondary efficacy parameters included time to next paracentesis, ascites signs and symptoms and overall survival (OS). Puncture-free survival was significantly longer in the catumaxomab group (median 46 days) than the control group (median 11 days) (hazard ratio = 0.254: p < 0.0001) as was median time to next paracentesis (77 versus 13 days; p < 0.0001). In addition, catumaxomab patients had fewer signs and symptoms of ascites than control patients. OS showed a positive trend for the catumaxomab group and, in a prospectively planned analysis, was significantly prolonged in patients with gastric cancer (n = 66; 71 versus 44 days; p = 0.0313). Although adverse events associated with catumaxomab were frequent, they were manageable, generally reversible and mainly related to its immunologic mode of action. Catumaxomab showed a clear clinical benefit in patients with malignant ascites secondary to epithelial cancers, especially gastric cancer, with an acceptable safety profile.